United Kingdom MHRA device registration 77788

Fully-implantable middle ear implant system sound processor

United Kingdom·Active implantable device (Directive 90/385/EEC only)·Cochlear Boulder LLC ·Registered Apr 29, 2021

Registration details

Device ID: 77788
Date Registered: Apr 29, 2021
Last Updated: Dec 22, 2022

Device classification

Device Type: Active implantable device (Directive 90/385/EEC only)
Devices: Fully-implantable middle ear implant system sound processor
Type: Active implantable Medical device

Manufacturer

Name: Cochlear Boulder LLC
Address: 5445 Airport Boulevard
Boulder, Colorado, United States
Created Date: Apr 29, 2021

Authorized Representative

Name: Cochlear Europe Ltd
Relationship Type: UK Responsible Person
Address: 6 Dashwood Lang Road Bourne Business Park
Addlestone, Surrey, England, United Kingdom
Postcode: KT15 2HJ

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About this record

Fully-implantable middle ear implant system sound processor is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 77788. The device is manufactured by Cochlear Boulder LLC from United States, classified as Active implantable device (Directive 90/385/EEC only). The authorized representative in the UK is Cochlear Europe Ltd.

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